FDA Lays Out Pediatric Study Requirements For Device Makers

Law360, New York (March 25, 2014, 4:39 PM EDT) -- The U.S. Food and Drug Administration on Tuesday published new guidance on when and how medical device manufacturers should conduct pediatric studies of the safety and effectiveness of their products, largely reiterating longstanding expectations.

By mostly parroting guidance from 2004, Tuesday’s document serves mainly as a reminder of device makers' obligations to show how younger patients at different stages of mental and physical development may be affected by their wares.

The FDA’s approach recognizes four pediatric categories up to age 21, including newborns, infants, children and...
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